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Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

Primary Purpose

Rotator Cuff Tendonitis, Bicipital Tendonitis, Subdeltoid Bursitis of the Shoulder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

diclofenac sodium

Matching Placebo

About this trial

This is an interventional treatment trial for Rotator Cuff Tendonitis focused on measuring Tendonitis, Bursitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years to 75 years of age
Onset of painful upper extremity tendonitis or bursitis, no more than 21 days prior to study entry
Eligible diagnoses are rotator cuff tendonitis, bicipital tendonitis or subdeltoid/subacromial bursitis of the shoulder, medial or lateral epicondylitis of the elbow, and DeQuervain's tenosynovitis of the wrist
Spontaneous pain with motion or resisted motion and tenderness to palpation over the involved tendon(s), bursa, or epicondyle
Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)

Exclusion Criteria:

Aspirin, or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (see Appendix B: for table of NSAIDs)
Opioid use within 3 days prior to study entry
Topical treatment, other than local ice or heat, applied to the painful region within 3 days prior to study entry
History of peptic ulcer disease within 1 year prior to study entry, any history of gastrointestinal bleeding, or coagulation disorder
A history of, or evidence for underlying articular disease such as osteoarthritis, rheumatoid arthritis, gout, or pseudogout (calcium pyrophosphate deposition disease)
Clinically significant and poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
A history of hypersensitivity to diclofenac or diclofenac-containing products
A history of intolerance to acetaminophen (rescue medication in this trial)
A history of skin sensitivity to adhesives (e.g. adhesive tape)
Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Topical diclofenac sodium patch

Topical patch identical in appearance to active comparator

Outcomes

Primary Outcome Measures

Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.

Secondary Outcome Measures

Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.

Full Information

NCT ID

NCT00640939

First Posted

March 18, 2008

Last Updated

August 5, 2008

Sponsor

Cerimon Pharmaceuticals

Collaborators

PPD

1. Study Identification

Unique Protocol Identification Number

NCT00640939

Brief Title

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Pain Due to Mild to Moderate Tendonitis or Bursitis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cerimon Pharmaceuticals

Collaborators

PPD

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist. The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.

Detailed Description

Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tendonitis, Bicipital Tendonitis, Subdeltoid Bursitis of the Shoulder, Subacromial Bursitis of the Shoulder, Medial Epicondylitis of the Elbow, Lateral Epicondylitis of the Elbow, DeQuervain's Tenosynovitis of the Wrist

Keywords

Tendonitis, Bursitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

308 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Topical diclofenac sodium patch

Arm Title

Arm Type

Placebo Comparator

Arm Description

Topical patch identical in appearance to active comparator

Intervention Type

Drug

Intervention Name(s)

diclofenac sodium

Other Intervention Name(s)

diclofenac

Intervention Description

15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Other Intervention Name(s)

placebo

Intervention Description

Matching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily

Primary Outcome Measure Information:

Title

Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years to 75 years of age Onset of painful upper extremity tendonitis or bursitis, no more than 21 days prior to study entry Eligible diagnoses are rotator cuff tendonitis, bicipital tendonitis or subdeltoid/subacromial bursitis of the shoulder, medial or lateral epicondylitis of the elbow, and DeQuervain's tenosynovitis of the wrist Spontaneous pain with motion or resisted motion and tenderness to palpation over the involved tendon(s), bursa, or epicondyle Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS) Exclusion Criteria: Aspirin, or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (see Appendix B: for table of NSAIDs) Opioid use within 3 days prior to study entry Topical treatment, other than local ice or heat, applied to the painful region within 3 days prior to study entry History of peptic ulcer disease within 1 year prior to study entry, any history of gastrointestinal bleeding, or coagulation disorder A history of, or evidence for underlying articular disease such as osteoarthritis, rheumatoid arthritis, gout, or pseudogout (calcium pyrophosphate deposition disease) Clinically significant and poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease A history of hypersensitivity to diclofenac or diclofenac-containing products A history of intolerance to acetaminophen (rescue medication in this trial) A history of skin sensitivity to adhesives (e.g. adhesive tape) Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Levitt, MD

Organizational Affiliation

Cerimon Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

PPD

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

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Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

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